FDA 483 - Laboratorio Reig Jofre, S.A. - April 05, 2019

An FDA inspection of Laboratorio Reig Jofre, S.A., a sterile drug manufacturer in Sant Joan Despi, Spain, from March 25 to April 5, 2019, revealed significant deficiencies. The firm failed to adequately investigate out-of-specification results, adhere to its own SOPs for change control and supplier qualification, and properly validate aseptic processes. Issues also included inadequate cleaning procedures, lack of required endotoxin testing, and insufficient laboratory control specifications, indicating a systemic lack of control over critical manufacturing and quality processes.